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Chosen by top companies to manage Quality, Risk and Compliance!

M-Files QMS helps companies improve and manage every aspect of quality, process flow, traceability, security and compliance. Because the M-Files Quality Management System is built using the M-Files Document Management system (DMS), including it’s Workflow Engine, all features and all integration of DMS are automatically included. M-Files QMS delivers a complete quality and compliance solution that has all the database functionality and all the ease of use features of DMS.

Additionally to DMS functionality, M-Files QMS enables:
  • The creation, management and complete life-cycle maintenance of Standard Operating Procedures (or SOP’s)
  • Complete employee Management including all HR and SOP functionalities
  • Complete Audit Trails with extensive Reporting
  • Corrective and Predictiove Actions and their Lifecycle Management (CAPA)
  • Extensive reporting and dash-boarding also in combination with tools such as SharePoint and SQL Server Reporting Services
Reliability & Performance

M-Files QMS makes it easy for businesses to improve their quality management systems and meet certification requirements with document and process management capabilities designed for organizations with strict quality and compliance needs.

Improve your quality procedures with a comprehensive set of features that assist with:

  • Quality standards such as ISO 9001:2015
  • CE marking or labeling
  • Compliance with FDA 21 CFR Part 11 and EU GMP Annex 11
  • Audits associated with all of the above.
Compliance with Regulations and Standards

M-Files QMS is ideal for companies in highly regulated industries:

  • Pharmaceutical and Life Sciences Companies
  • Health Care Institutions
  • Petrochemicals and other process-related manufacturing
  • Food production
  • Transportation, including aviation and automotive
  • Mining and Drilling
M-Files QMS Features
  • Create and Manage SOP’s
    Manage the creation, management and implementation of SOP’s including training of personnel affected by SOP’s and the updating of the Quality Manual
  • Manage all aspects of Training
    Manage course lists and materials. Record and track training. Make sure your personnel is up to date on all SOP’s that apply to them.
  • Maintain Inventories
    Build and manage company-specific inventories and lists, including software and hardware inventories, with full version history.
  • Manage Electronic Signatures
    When documents must be approved or authorized, M-Files QMS supports three signing options: built-in digital signing, external digital signing services and handwritten signatures.
  • Validate QMS Implementation
    Validate your implementation and assure compliance.
  • Manage Corrective and Preventive Actions (CAPA’s)
    Efficiently and effortlessly record and handle deviations and corrective actions, doing this in conformity to your own SOP‘s.
  • Efficiently handle Document Management Tasks
    Use the prize winning M-Files DMS that is an integral part of M-Files QMS, to handle all aspects of version control, workflows, PDF management and more.